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EDUCATION AND DEBATE: Stephen Senn Individual response to treatment: is it a valid assumption? BMJ 2004; 329: 966-968 [Full text]

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Every Prescription a Clinical Trial

Alfred P J Lake   (4 November 2004)

Every Prescription a Clinical Trial 4 November 2004
Alfred P J Lake, Consultant in Anaesthesia & Pain Management Glan Clwyd Hospital, LL18 5UJ Send response to journal: Re: Every Prescription a Clinical Trial	Patients have never responded consistently to treatment, and, additionally, every time a prescription is written (except for identical twins) what effectively begins is a clinical trial with n=1. Evidence based medicine or evidence based clinical practice is the judicious application of best current knowledge to the condition and values of the individual patient (1) and should, therefore, allow for individualised treatment which may well involve a drug different to the "best" identified after systematic review and can the gold standard randomised controlled trial really deliver the sought for certainty when we know that it is indeed impossible to identify which patients will respond to the treatment? Trials organised by pharmaceutical companies are designed to demonstrate the superiority of their product over a competitor to ensure optimum market share with little thought of the individual patient recipient. Promotion follows to ensure product recognition at the point of "sale". Examining published study results in many areas it quickly becomes apparent that some subjects do much better with the drug that is found to be statistically inferior. To illustrate this point consider intravenous regional sympathetic block (IRSB) which is not considered to have satisfied the demands of rigorous scientific evaluation. Systematic review combined with a double-blind evaluation has failed to support IRSB as an evidence-based treatment [2] yet individual patients are reported as deriving very significant benefit, which, in this typical case was eighteen months pain relief following two treatments [3]. As it remains, however, a useful and valued component of the planned staged approach to the management of chronic regional pain syndrome (CRPS) type 1, many pain clinicians will continue to include it or an equivalent intervention in their armamentarium [4]. An additional problem which regularly comes to our attention is the removal from the market of valuable drugs (though often in limited indication) which are effective in, and appropriate for, many individual patients. 1.Muir Gray JA. Evidence based policy making. BMJ 2004; 329: 988-9 2.Jadad AR, Carroll D, Glynn CJ, McQuay HJ. Intravenous regional sympathetic blockade for pain relief in reflex sympathetic dystrophy: a systematic review and a randomised, double-blind crossover study. J Pain Symptom Manage 1995; 10: 13-20. 3.Vijayan R, Low KH. Pain relief with intravenous regional guanethidine in post-traumatic reflex sympathetic dystrophy ? a case report. Med J Malaysia 1993; 48: 236-9. 4.Lake APJ. Intravenous regional sympathetic block: Past, present and future? Pain Res Manage 2004; 9: 35-7. Competing interests: None declared